ES2757575T3 - Autoinjector - Google Patents

Abstract

An autoinjector (10) comprising: an outer casing (12, 14) having a proximal end (18) and a distal end (16); an inner casing (84); a cartridge (74) located within said internal casing (84), said cartridge (74) containing a medicament, said cartridge (74) further comprising a plunger (76) within said cartridge (74); an actuator assembly (28) comprising an upper member (30) and a lower member (32), said lower member (32) having an upwardly extending member (52, 54), said member (52, 54) which extending upward is locked with said upper member (30), a compressed spring (44) extending between said lower member (32) and said upper member (30), a first trigger (22) being operative to unlock said element (52, 54) extending upwardly from said upper member (30); said first trigger (22) being located at said distal end (16), said first trigger (22) being operative to cause activation of said actuator assembly (28); and a second trigger (98) being located at said proximal end (18), the arrangement being such that said second trigger (98) must be activated to allow the actuation of said first trigger (22), wherein said second trigger ( 98) is activated by a user pressing the autoinjector (10) against a resilient surface, where said actuator assembly (28) is separated from said first trigger (22), said second trigger (98) is designed to move said assembly (28) ) actuator closer to said first trigger (22) to thereby allow said first trigger (22) to actuate said actuator assembly (28), characterized in that said cartridge (74) has one end thereof sealed by a member (80) pierceable, said pierceable member being a plug (80), said autoinjector (10) further comprises a needle distributor (64), said needle distributor (64) has first and second piercing tips (68, 70), is with said first and second drilling tips (68, 70) in fluid communication, said actuator assembly (28) is arranged to move an actuator from a first storage position to an activated position where said first drilling tip (68) extends outwardly of said outer housing (12, 14) at said proximal end (18) and said second piercing tip (70) pierces said pierceable member (80), said actuator assembly (28) further includes a plunger rod (60), said plunger rod (60) engages said plunger (76) to cause said first piercing tip (68) to extend outwardly of said outer housing (12, 14) and said second piercing tip (70) to pierce said plug (80) ) of said cartridge (74), said autoinjector (10) further includes a spring (112) which pushes said needle dispenser (64) into a retracted position after deployment thereof.

Description

DESCRIPTION

Autoinjector

Field of the Invention

The present invention relates to a medical device and more particularly relates to an autoinjector for injecting a medication into the body of a patient.

Background of the Invention

Autoinjectors are well known in the art and, as mentioned above, are used to inject a drug into a patient's body. The injection is usually done by the patient. Certain allergic reactions, such as exposure to peanuts, shellfish, certain drugs, toxins, and the like, can cause an allergic reaction in some people. In general, the allergic reaction will lead to anaphylactic shock that will cause a sharp drop in blood pressure. Other reactions such as constriction of the airway may occur.

To respond to such a reaction, an individual may wear an auto-injector to administer an injection of a substance that can provide relief from the allergic reaction. Typically, such an injection is epinephrine (adrenaline). As mentioned above, autoinjectors are known in the prior art and come in different configurations. Typically the user is supposed to place a first end against the body surface (typically a thigh) and then a trigger is activated to start the injection process. However, given the user's condition at the time, confusion can cause the user to place the wrong end against the thigh. This can cause the user to operate the autoinjector away from the intended injection sight. Naturally, this is highly undesirable as the user generally only takes a single dose and, unless other sources are available, the allergic reaction will not be treated.

US 5,137,516 describes a self-injection device comprising a body for containing a container of a substance to be administered, a release mechanism and means controlled by the release mechanism for discharging the substance. The body is made up of two parts, one part is mobile with respect to the other, where one part has a trigger and the release mechanism is operated in part by the operation of a trigger from one part and is operated in part by the movement of the other party relative to it, but is only fully triggered by the operation of the trigger and the movement of the other party. Therefore, the download media cannot be accidentally triggered.

US 2006/0129122 A1 discloses a drug delivery device for the treatment of anaphylaxis. The drug delivery device contains sufficient epinephrine solution for injection of at least two doses of 0.15 or 0.3 ml epinephrine solution each. In syringe assemblies according to US 2006/0129122 A1, the ampoule includes a rear end that is potentially open to slidably receive a plunger. The plunger and plunger piston can move axially within the ampoule bore by applying axial force against the axis of the plunger. The plunger will thus force the epinephrine solution through a hollow needle assembly at a forward end of the ampoule when the plunger is pressed toward the front or needle end, i.e., toward the needle. The needle assembly of US 2006/0129122 A1 either comprises cartridges with a fixed needle or a cartridge closed by a septum and having a movable dispenser with a second piercing tip.

Summary of the Invention

Therefore, an object of the present invention is to provide an autoinjector that will result in consistent and reliable actuation of the autoinjector.

In accordance with the present invention, there is provided an autoinjector comprising an outer shell having a proximal end and a distal end; an inner casing; a cartridge located within said internal casing, said cartridge contains a medicament, said cartridge further comprising a plunger inside said cartridge; an actuator assembly comprising an upper member and a lower member, said lower member having an upwardly extending member, said upwardly extending member being locked with said upper member, a compressed spring extending between said lower member and said upper member, said first trigger is operative to unlock said element extending upward from said upper member; a first trigger is located at said distal end, said first trigger is operative to cause actuation of said actuator assembly; and a second trigger located at said proximal end, the arrangement is such that said second trigger must be activated to allow activation of said first trigger, wherein said second trigger is activated by a user pressing the autoinjector against a resilient surface, wherein said actuator assembly is separate from said first trigger, said second trigger being designed to move said actuator assembly closer to said first trigger to thereby allow said first trigger to actuate said actuator assembly. The cartridge has one end thereof sealed by a pierceable member, said pierceable member being a plug, said autoinjector further comprising a needle distributor, said needle distributor having first and second piercing tips, said first and second piercing tips being in fluid communication, said actuator assembly being arranged to move an actuator from a first storage position to an activated position where said first piercing tip extends out of said outer casing at said proximal end and said second piercing tip pierces said pierceable member, said actuator assembly further includes a plunger rod, said plunger rod engaging said plunger to cause said first piercing tip to extend outwardly from said outer casing and said second piercing tip for piercing said cap of said cartridge, said auto-injector further includes a spring which pushes said needle dispenser into a retracted position after deployment thereof.

The outer shell is preferably made up of two pieces secured together. The securing means can be typical, such as the use of clips and / or fastening devices, such as screws.

The cartridge can be selected from those known in the art. The cartridge is typically an elongated container containing a medicine. The drug is contained within the cartridge by having at least one end thereof sealed by a pierceable member. The pierceable member is the cartridge stopper that seals the internal cavity.

The needle carries a staked needle which will have a first and second piercing tips as is known in the art. The first and second piercing tips are in fluid communication, which is necessary so that the medication can flow from the cartridge to the injection site.

The actuator assembly comprises upper and lower members. The terms "top" and "bottom" are relative, and in the current instant application, the word top refers to the part of the actuator assembly closest to the distal end of the autoinjector. Rather, the term "lower" refers to the part of the actuator assembly that is closest to the proximal end of the autoinjector.

The actuator assembly secures the top portion and the bottom portion along with compressed springs mounted therebetween. A trigger mounted on the distal end is designed to release the lower limb from the upper limb. The springs are used to drive the lower portion with enough force to cause the needle to extend out of the outer casing and the cartridge to be pierced by the needle.

As mentioned earlier, there is a first trigger located at the distal end while there is a second trigger located at the proximal end. The arrangement is such that only when the patient or the user actuates the second trigger by pressing the autoinjector against the site to be injected, will it cause the actuator assembly to move to a position where it can be actuated by the first trigger.

After actuation, the needle distributor will return to such a position that the needle no longer protrudes from the outer casing.

The autoinjector is preferably provided with a circuit board and a battery. Many different features can be incorporated. Therefore, one of the main problems with autoinjectors is that the patient who requires their use may tend to forget to wear the autoinjector at all times. To overcome this, the autoinjector could be electronically connected to a user's cell phone. Once a certain distance exists between the phone and the autoinjector, the user is reminded that the autoinjector is not present. The reminder can be any suitable, even auditory or visual.

Other features could include a provision that once activated, will notify one or more sites that it has been used. This can be used, along with GPS capabilities, to locate usage and ensure the patient is not distressed. For example, the device might have the ability to send a message to a doctor or other medical facility reporting that it has been used.

The device could also be used to control the device's exposure to environmental conditions. This can be important with certain medications that are heat sensitive. If the device is exposed to enough heat for a certain time, a message could be sent informing that the medication may have been compromised. This could be used to automatically resend a replacement device to the user.

Similarly, the device could also be programmed to automatically reorder when the expiration date is reached.

Furthermore, if for any reason a second injection is required, the ability to locate other devices in the immediate area could be programmed.

The signaling arrangement with the device that has been used could easily be integrated into the device. Therefore, two metal contacts could be in a normally separate position before actuation. Once the actuator assembly has been moved, this could allow the two electrical contacts to contact each other and thus send a signal.

Brief description of the drawings

Having thus generally described the invention, reference will be made to the accompanying drawings illustrating an embodiment thereof, in which:

Figure 1 is an exploded view of the autoinjector of the present invention;

Figure 2 is a sectional view of the autoinjector when it is in a stored position;

Figure 3 is a sectional view illustrating removal of the plug;

Figure 4 is a sectional view illustrating the start of pressing the second trigger;

Figure 5 is a sectional view illustrating the start of actuation of the first trigger;

Figure 6 is a sectional view illustrating the autoinjector during actuation;

Figure 7 is a sectional view illustrating the fully activated autoinjector;

Figure 8 is a sectional view illustrating the autoinjector at the end of the actuation;

Figure 9 is a sectional view illustrating retraction of the needle;

Figure 10 is a sectional view illustrating the worn auto-injector with the cover replaced;

Figure 11 is a cross-sectional perspective view of the autoinjector when it is in the position shown in Figure 3;

Figure 12 is a cross-sectional perspective view of the autoinjector in the position illustrated in Figure 4; Figure 13 is a cross-sectional perspective view of the autoinjector in the position illustrated in Figure 5; Figure 14 is a cross-sectional perspective view of the autoinjector when it is in the position shown in Figure 6; and

Figure 15 is a cross-sectional perspective view of the autoinjector when it is in the position illustrated in Figure 7.

Detailed description of the invention

With reference to the drawings in greater detail and by reference characters thereto, an autoinjector generally designated by reference numeral 10 is illustrated. Autoinjector 10 is designed to inject or administer an injection of a substance.

The autoinjector 10 has an outer shell characterized by an outer shell first half 12 and an outer shell second half 14. For the purposes of this disclosure, the applicant will refer to a distal end generally designated by reference numeral 16 and a proximal end generally designated by reference numeral 18. As used herein, the term "distal end" it refers to the end far from the injection site while the term "proximal end" refers to the end closest to the injection site.

At the distal end 16, a trigger 22 is provided in the form of a push button. Mounted immediately below and somewhat within the trigger 22 is a battery 24 and a printed circuit board 26. The printed circuit board 26 is used to control the electronic functions of the device as will be discussed later. A spring 34 pushes said trigger 22. A pair of metal contacts 29 extend downward from the printed circuit board 26. They separate before actuation.

The autoinjector 10 includes an actuator assembly generally designated by reference numeral 28. Actuator assembly 28 includes an upper member generally designated by reference numeral 30 and a lower member generally designated by reference numeral 32.

The upper member 30 has a recessed upper surface 36 having a plurality of openings 38 formed therein. There are four such openings 38. On each side, a pair of lugs 40 are provided, each of which has a passageway generally designated by reference numeral 42 extending through them.

Lower member 32 includes a base 46 with a pair of upwardly extending side walls 48, 50. On a first side, a pair of legs 52 is provided which are slightly spaced apart and have tabs 54 at their upper end. Similarly, legs 56 are provided on the opposite side with each of the tabs 58 formed on them. A pair of compressed springs 44 extend around legs 52, 56 between lower member 32 and upper member 30. A recess 31 is provided at the top edge.

Located between the upper member 30 and the lower member 32 is a movable piston 60 having diamond-shaped protrusions 62 on either. The protrusions 62 fit into the recess 31.

A needle dispenser 64 has a staked needle 66 with a first piercing tip 68 and a second piercing tip 70. A cartridge 74 contains a drug 76. Cartridge 74 has a plunger 78 inside its body and a pierceable top 80.

Autoinjector 10 has an inner casing 84. Inner casing 84 has a cylindrical base 86 with protuberances 88 positioned thereon. Above the protuberances 88, a circular stop flange 90 is provided. The upper portion of the inner casing 84 includes grooves 92 to thereby divide the inner casing 84 into leg-shaped structures. In the upper portion of the inner casing 84, tabs 94 are provided which are designed to engage with the upper surface 36 of the upper member 30 to thereby retain the inner casing 84 in position.

At its proximal end 18, autoinjector 10 is provided with a trigger 98. Trigger 98 has a bottom wall 100 with an opening 102 formed therein to allow the staked needle 68 to extend outward from there. Trigger 98 also has a front wall 104 and a rear wall 106. The tabs 108 extend upward from there. Also provided are inverted U-shaped members 110 that are designed to engage with protrusions 88 of inner casing 84 to thereby interconnect the two members. A housing 114 has a flange 116 with a coil spring 112 extending between the trigger 98 and the needle distributor 64 on the housing 114.

A cover 116 is designed to extend around trigger 98. Cover 116 is removable when the use of autoinjector 10 is required.

In operation, to initiate actuation, autoinjector 10 is depressed such that trigger 98 is against the body surface where the injection will be placed. Pressing the trigger 98 will cause the actuator assembly 28 to move upward. This places the actuator assembly 28 in a position where the trigger 22 will be effective in activating the device. This position is illustrated in Figures 4 and 5 of the drawings. The patient will press the trigger 22 which will then release the tabs 54 and 58 on the legs 52 and 56 respectively. This allows the springs 44 to drive the plunger rod 60 against the plunger 76. This results in the first piercing tip 68 extending out of the outer casing while also causing the second piercing tip to pierce the pierceable upper portion 80. cartridge 74. The medicine is then injected into the patient.

Subsequently, after injection, spring 112 will cause an upward movement of needle dispenser 64 and vial to thereby store the needle within the autoinjector.

Claims (8)

1. An autoinjector (10) comprising: an outer casing (12, 14) having a proximal end (18) and a distal end (16); an inner casing (84); a cartridge (74) located within said internal casing (84), said cartridge (74) containing a medicament, said cartridge (74) further comprising a plunger (76) within said cartridge (74); an actuator assembly (28) comprising an upper member (30) and a lower member (32), said lower member (32) having an upwardly extending member (52, 54), said member (52, 54) which extending upward is locked with said upper member (30), a compressed spring (44) extending between said lower member (32) and said upper member (30), a first trigger (22) being operative to unlock said element (52, 54) extending upwardly from said upper member (30); said first trigger (22) being located at said distal end (16), said first trigger (22) being operative to cause activation of said actuator assembly (28); and a second trigger (98) being located at said proximal end (18), the arrangement being such that said second trigger (98) must be activated to allow the actuation of said first trigger (22), wherein said second trigger (98) ) is activated by a user who presses the autoinjector (10) against a resilient surface, wherein said actuator assembly (28) is spaced from said first trigger (22), said second trigger (98) is designed to move said actuator assembly (28) closer to said first trigger (22) to thereby allow said first trigger (22) actuates said actuator assembly (28), characterized in that said cartridge (74) has one end thereof sealed by a pierceable member (80), said pierceable member being a plug (80), said autoinjector (10) further comprises a needle distributor (64), said needle distributor (64) has first and second piercing tips (68, 70), said first and second piercing tips (68, 70) being in fluid communication, said actuator assembly (28) is arranged to move an actuator from a first storage position to an activated position where said first piercing tip (68) extends out of said outer casing (12, 14) at said end (18) proximal and said second piercing tip (70) pierces said pierceable member (80), said actuator assembly (28) further includes a plunger rod (60), said plunger rod (60) engages said plunger (76) to cause said first piercing tip (68) to extend out of said housing (12, 14 ) outer and said second piercing tip (70) for piercing said cap (80) of said cartridge (74), said auto-injector (10) further includes a spring (112) which pushes said needle distributor (64) into a position retracted afterwards of its deployment. 2. The autoinjector (10) of claim 1, further including a cover (116) for said proximal end (18). The autoinjector (10) of claim 2, further including a printed circuit board (26) and a battery (24) mounted within said outer housing (12, 14) at said distal end (16). The autoinjector (10) of claim 1 including a pair of compressed springs (44) extending between said lower member (32) and said upper member (30). The auto-injector (10) of claim 4 wherein said springs (44) each extend around a respective upwardly extending member (52, 54). 6. The autoinjector (10) of claim 1 further including a spring (34) that pushes said first trigger (22). 7. The autoinjector (10) of claim 1, further including a detector (29) for detecting actuation of the autoinjector (10). The autoinjector (10) of claim 7, wherein said detector comprises a first and a second contact (29), said contacts being maintained in a normally spaced relationship, said contacts contacting each other after actuation of the actuator assembly (28) .